SGS | Your 360 cosmetics partner

Your 360° cosmetics testing partner Science inspired, Quality Driven

SGS France offers an extensive research network, ensuring no detail is overlooked. Our holistic 360º- service for cosmetic product development caters to every stage of the process, with our expert team on hand as your reliable partners throughout.

Our cosmetics include:

TOLERANCE & TOXICOLOGY IN VITRO

MICROBIOLOGY STUDIES

CHEMICAL ANALYSIS

CLINICAL TESTS

REGULATORY EXPERTISE

SPF TESTING

An extensive expertise

Our international laboratories

Tokyo • C linical testing

Our twelve laboratories, centrally managed from France, offer harmonized quality standards. Five of them are localized in France with a comprehensive scientific expertise, enabling seamless multicentric studies and an integrated approach to cosmetic evaluation.

Seoul • Clinical testing/ ISO 9001 • SPF testing

Rouen

Brest

Guangzhou • Clinical testing/ ISO 9001

Rouen - BPL (ANSM et Cofrac) • Chemical analysis • Ecotoxicology • Biodegradability Brest • Microbiology • Genetic toxicology/ GLP

Lyon • In vitro tolerance and toxicology/ GLP ANSM • Clinical testing/ ISO 9001 Bordeaux • Clinical testing/ ISO 9001 • In vitro tolerance and toxicology/ GLP • EU regulatory expertise Saint-Étienne • Clinical testing/ ISO 9001

Singapore • Clinical testing/ ISO 9001

Lyon

Bordeaux

Saint Étienne

Cape Town • Clinical testing/ ISO 9001

Bucarest • Clinical testing • SPF testing

Sofia • Clinical testing/ ISO 9001 • SPF testing

Some of our services are eligible for the Research Tax Credit (CIR). To learn more, please feel free to contact us at the following address: fr.cosmeticsales@sgs.com

Improving safety, quality, efficacy and sustainability of cosmetics

CHEMICAL ANALYSES

Data issued from laboratory analyses also allow feeding the PIF (Product Information File)- Part A • chapter “physical/chemical characteristics of substances and finished products” • chapter “impurities, traces and information on the packaging material”

Chemical Analyses - Dosages of substances

Physico-chemical analyses

Search for traces of prohibited (Annex II) or restricted substances (Annex III, V)

Ingredient assay (majority, function in product)

To characterize a formula and establish the specifications sheet and MSDS

Our network of laboratories and clinical facilities offer fully integrated solution packages.

Preservatives: parabens, phenoxyethanol, MIT/CMIT, triclosan, potassium sorbate, sodium benzoate, benzyl alcohol, dehydroacetic acid, salicylic acid...

Pure or diluted pH

When analytical and environmental impact studies are required? Our experts offer customer-centric and customized programs for: • Ingredients and raw materials control upon receipt • Product development phase (R&D): before and after stability, packaging migration studies • Production phase and quality control: check of manufacturing batches in factory and post-market surveillance

Environmental impact studies This service studies the behavior and impact of ingredients, raw material or finished products on different ecosys- tems (target populations). • Biodegradability studies: OECD 301, 302, 306, 311 • Ecotoxicity studies: • Fresh water: OECD 201, 202, 203, 209, 210, 211, 212, 215, 221, 236 • On sea water: EN ISO 10253, FD ISO 14669, ISO 16778...

• Some of these studies can be performed under GLP (Good Laboratory Practices) • EASZY assay (OECD 250)

Heavy metals (lead, cadmium, arsenic, mercury...)

Solar filters (Annex VI): organic and inorganic (TiO2 titanium dioxide, ZnO Zinc Oxide) Furocoumarines

Viscosity

Allergens (list of 26 or 57)

Vitamins (A, C, E, PP, ProB5)

Flash Point

Phthalates

Alcohols

Density

Formaldehyde

Soap

Mass/Weight/Volume

Pesticides

Surfactants

Perfume profile and content

Nitrosamines-NDELA

Fluorides, silicates/silicas

Aerosol: pressure, active load, propellant

PAH: Polycyclic Aromatic Hydrocarbons

Glycerin

Aw, water content

BPA: Bisphenol A

Humectants (sorbitol, glycerol)

Dry Extract

Packaging migration studies (container/content interactions)

Aluminium salts, zeolites

Surfactants (anionic, cationic, amphoteric, non-ionic)

Ingredients Raw materials

Packaging Finished products

Ecotoxicity testing on corals

PFAS : Substances per- and polyfluoroalkylées

Efficacy A clinical efficacy department at the cutting edge of technology. To offer high-tech service, SGS IDEA and SGS IEC invest a lot in performing and innovative equipments. Our priority is to adapt our techniques and our know-how to evolving technologies and to your product’s claims.

CLINICAL TESTS

Our answer for your claims: MAKE-UP • Lengthening, curling, volume of eyelashes • Long lasting, waterproof, sweatproof • Color, glossy, covering power, • make-up removal efficacy ANTI-AGING RANGE • Anti-wrinkles, smoothing, anti-ageing • Anti dark spots/lightening effect • Firming/tensing effect SKINCARE PRODUCTS • Skin radiance • Dermoprotection, repair • Soothing effect

• Cells renewal • Depilatory effectiveness • Skin suntan • Firming/slimming effect

• Microbiome friendly • Anti-greasiness, mattifying • Moisturizing • Anti-puffiness, dark circles • Anti-pollution HAIR CARE • Scalp: hydration, sensitivity, • sebum regulation • Hair shine • Thermoprotection • Anti-frizz, curls quality • Anti dandruff activity HYGIENE & BODY • Deodorant effectiveness • Anti-perspirant effectiveness

3 clinical centers in France 7 centers outside France 25 000 active volunteers

Instrumental methods: Corneometer ® , D’squames ® + Visioline VL 650 ® , Sebumeter ® , Sebutape ® , TEWL (Tewameter TmHex ® + Vapometer ® ), Silicon replicas, photo Bench + VISIA CR ® , image analysis, Chromameter ® , Mexameter ® , Dermal Torque Meter ® , Cutometer ® , pH meter ® , infrared Camera, gravimetry, Scanning Electron Microscopy (SEM), centimetry, C-Cube ® . Clinical evaluations: clinical scoring by a dermatologist or trained experts (skin dryness, seborrhoea, wrinkles, etc.), sniff tests, self evaluations by the volunteer, grading on pictures, acceptability, well-being questionnaire.

NEW

Consumer tests on cosmetics, detergents, and food supplements

Tolerance

CLINICAL TESTS

Trusted expertise in tolerance testing. Our team of specialists, Eurotox experts, doctors and dermatologists will provide support for study design, implementation and interpretation of results.

We offer a number of different methods including: simple or repeated patch test, open test, elbow fold, use test under control (dermatological, ophtalmological, gynaecological, pediatric, odontological…), use test performed by a beautician (professional products).

The tolerance evaluation: • Skin tolerance

Capabilities: • 3 clinical centers in France, 1 in Romania, and 1 in Bulgaria • 15 rooms with controlled temperature and humidity • 1 room simulating extreme climatic conditions • 4 photo laboratories in France and 1 in Bulgaria

Our experts (dermatologists, ophthalmological, pediatricians,

and gynecological) advise you on your tolerance studies. SGS IDEA and SGS IEC also have a state-of-the-art clinical efficacy department: photo booth, image analysis. Our priority is to adapt our techniques and expertise to technological developments and your product’s claims, in compliance with Good Clinical Practices.

• Ocular tolerance • Mucous tolerance • Non comedogenicity • Sensitization potential • Phototoxicity

Regulatory expertise

REGULATORY EXPERTISE

The regulatory expertise required for cosmetics involves a comprehensive understanding of various laws, guidelines, and standards that govern the manufacturing, labeling, marketing, and distribution of cosmetic products.

1,500 expert assessments per year 3,000 ingredients recorded in our toxicological database

Before launching your products • Pre-expertises

Other regulatory services • Bibliographical research • Regulatory monitoring

With over 15 years of experience, SGS IDEA and its team, including toxicologists (including a certified ERT expert), are at your service to support the market launch of your cosmetic products that are safe for consumers in accordance with the European market such as: • Ingredient review • Product safety • Accurate labeling • Claims substantiation • Updates according to changes in regulations, guidelines, standards..

• Formula validation • Labeling validation • MOS calculation (Margin of Safety) European regulation

• Toxicological synthesis for ingredients (TRA: Toxicological Risk Assessment) • Regulatory and technical advice • Equivalence certificates (raw materials/claims)

• Safety assessment (Part B) • Safety report (Part A + B) • Product Information File • European Commission notification (CPNP)

SPF testing SGS IDEA and SGS IEC have been involved in vitro and in vivo sunscreen testing for many years, relying on a continuous improvement approach to ensure our customers a high level of reliability in the results communicated to them.

SPF TESTING

In vitro Regulatory and screening tests • UVA-PF determination • Critical wavelength • Boots star rating • SPF assessment • Batch control • Spectral photostability Capabilities • 1 fully equipped lab • Solarlight LS-1000 sun simulator • Labsphere UV-2000 spectrophotometer • Sunbot («Double plate» method) • Multiport solar simulators Protocols • ISO 24443 • ISO 23675 - NEW -

In vivo Clinical testing • SPF determination • UVA PF determination

• Water resistance • Sand resistance • Sweat resistance • Specific protocols: SPF wet skin, salt water resistance Capabilities • Jacuzzi and sauna • ISO standards Protocols • Australia/New Zealand standard

• For each tested product, the obtained value is consistently close to the reference value. The Z-scores recorded by our laboratories always fall within the range of-1 to +1, demonstrating their expertise. This also ensures that the results produced are reliable and meet the expected quality standards.

Strict compliance of our study conditions with the current international methods, regular training of our teams, internal audits carried out several times a year, and participation in inter-laboratory proficiency testing schemes organized by BIPEA * , in accordance with ISO/CEI 43-1, are key elements of this approach.

*Interprofessional Bureau of Analytical Studies, Paris, France - www.bipea.org BIPEA is a non-profit organization whose mission is to challenge the performance of test laboratories vis-à-vis their results, on an international level.

4,600 studies carried out in 10 years 22 years of experience in suncare testing 2,800 products tested in 10 years

• ISO 24444 • ISO 24442

• Boots star rating • Cosmetics Europe

Microbiology With more than 20 years experiences in industrial microbiology and its team of microbiologist experts, SGS IDEA offers in its Brest laboratory all the microbiological studies required by the cosmetic industry, such as: challenge tests/quality control/identification/efficacy/stability studies.

MICROBIOLOGY STUDIES

Stability studies according to ISO 18811 guideline • Determination of the date of minimum durability • Estimation of PAO (Period After Opening) • Accelerated ageing • Protocol adapted to the galenic and the packaging of the product • Specific protocols on demand: daylight stability, temperature cycles… Efficacy studies • Bactericidal activities EN 1276 • Fungicidal activities EN 1650 • MIC/MBC determination • Anti-acne (propionibacterium acnes) • Anti-dandruff (malassezia furfur) • Microbiome friendly evaluation • Specific protocols on demand

Risk evaluation according to the ISO 29621 Preservative efficacy tests (Challenge tests)

Quality control according to ISO 17516 norm microbial limits for cosmetics • Mesophilic aerobic bacteria ISO 21149

• Yeast & Molds ISO 16212 • Specified microorganisms: • Pseudomonas aeruginosa ISO 22717 • Staphylococcus aureus ISO 22718 • Escherichia coli ISO 21150 • Candida albicans ISO 18416 • Identification of micro-organisms (MALDI-TOF and phenotypic methods) Quality control: other methods

• ISO 11930 and screening • European Pharmacopoeia • US Pharmacopoeia • Plant and specific strains • Special protocols on demand (wipes, solid soaps, powders…) • Water activity measurement ISO 29621

• Filtration quality control • European Pharmacopoeia • US Pharmacopoeia

In vitro tolerance & toxicology Establishing the safety and toxicological profile of a cosmetic and its ingredients is the most critical aspect for obtaining regulatory approval. Toxicology testing aims to identify if the cosmetic product or an individual ingredient has the potential to cause harm to an organism.

TOLERANCE & TOXICOLOGY IN VITRO

SKIN SENSITIZATION • DPRA OECD 442C • KeratinoSens OECD 442D • h-CLAT OECD 442E • SENS-IS test on Reconstructed Human Epidermis TOLERANCE TESTS ON MUCOUS MEMBRANES • Oral, gingival, vaginal BIOCOMPATIBILITY FOR MEDICAL DEVICE • Cytotoxicity ISO 10993-05 • Skin irritation ISO 10993-23 • Skin sensitization ISO 10993-10 • Genotoxicity ISO 10993-03

Our capabilities OCULAR IRRITATION POTENTIAL • Agarose gel diffusion test • Neutral Red Release test • Het-Cam

• Skin corrosion test on Reconstructed Human Epidermis OECD 431 PHOTOTOXICITY • Phototoxicity on fibroblasts (3T3 NRU) OECD 432 • Phototoxicity on Reconstructed Human Epidermis OECD 498 TOXICITY • Acute toxicity test (3T3 model), OECD 129 GENETIC TOXICOLOGY • Ames test (OECD 471) • Micronucleus test (OECD 487)

With more than 20 years of experience on cosmetics, SGS IDEA and SGS IEC assesses the tolerance of cosmetic formulations and toxicity evaluation of cosmetic ingredients, but also of chemical and medical devices. With protocols that follow OECD international guidelines, SGS IDEA and SGS IEC can offer different strategies to assess different toxicological parameters: • Ocular and skin irritation potential

• Human Corneal epithelium test • (HCE EpiOcular test) OECD 492 • Isolated Chicken Eye Test (ICE) • OECD 438 • Bovine Corneal Opacity and Permeability (BCOP) OECD 437 SKIN IRRITATION & CORROSION POTENTIAL • Skin irritation test on Reconstructed Human Epidermis OECD 439

• Phototoxicity • Genotoxicity • Sensitization potential

Your 360° cosmetics testing partner Science inspired, Quality Driven

Contact us SGS France 29, Avenue Aristide Briand 94111 Arcueil, France

fr.cosmeticsales@sgs.com sgs.com/en-fr SGS Cosmetics & Hygiene

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